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Study of HuL001 in Relapsed/Refractory Multiple Myeloma Patients

NCT07210047 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-10-07

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the antibody drug HuL001, combined with

Lenalidomide/Dexamethasone works to treat Multiple Myeloma patients. It will also learn about the safety and tolerability of the therapeutic combination. The objectives of this study are:

1. To evaluate the safety and tolerability of HuL001 (in combination with Len/Dex).
2. To evaluate the efficacy of HuL001 (in combination with Len/Dex).

Researchers will use the antibody drug HuL001, combined with Len/Dex, to see if this works for Multiple Myeloma therapy.

Participants will:

* Receive HuL001 antibody injections every 2 weeks
* Take Lenalidomide for 21 consecutive days each month
* Take Dexamethasone every 1 week
* Visit the clinic on scheduled days for checkups and tests
* Keep a diary of their symptoms and Myeloma responses.

Conditions

  • Multiple Myeloma Refractory

Interventions

BIOLOGICAL

HuL001-10 mg/kg

Anti-ENO1 monoclonal antibody

BIOLOGICAL

HuL001-15 mg/kg

Anti-ENO1 monoclonal antibody

DRUG

Lenalidomide and Dexamethasone

Lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM)

Sponsors & Collaborators

  • HuniLife Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Maisie Huang, PhD · HuniLife Biotechnology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2027-11-30
Completion
2028-01-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07210047 on ClinicalTrials.gov